Congressional hearings are being triggered by allegations that agencies concealed FDA warnings from poor minority women targeted for the injections.

BY CELESTE MCGOVERN

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Posted 12/26/13 at 9:59 AM

WASHINGTON — Hundreds of thousands of impoverished women and girls in both the U.S. and Africa are not being told about dangerous side effects associated with a contraceptive injection that is heavily promoted by the Bill & Melinda Gates Foundation (BMGF), USAID, Planned Parenthood and a collection of “racist” family-planning groups, a human-rights report alleges.

The scathing report from the Washington-based Rebecca Project for Human Rights, a group that advocates for vulnerable women and girls in the U.S. and Africa, accuses the Gates Foundation of colluding with family-planning organizations to deliberately conceal known risks of the injectable hormonal contraceptive, Depo-Provera, manufactured by the Pfizer pharmaceutical company, to promote a “population-control ideology.”

Melinda Gates, the wife of Microsoft founder Bill Gates and a Catholic, made pharmaceutical birth control her “signature issue” and launched a Family Planning Summit in London in July 2012, securing $4 billion from her foundation, from tax-funded government aid agencies around the world including USAID and from a number of NGOs, to encourage 120 million additional women globally to use contraceptive drugs.

Kwame Fosu, the Rebecca Project’s human-rights lawyer, who wrote the report on Depo-Provera published in June, said it “tells the story of an egregious and smoldering human tragedy driven by profit at any cost and a ‘population control’ ideological agenda.” The report names a collection of prominent family-planning funders, including the Gates Foundation, USAID, the Population Council, the Ford Foundation, the Rockefeller Foundation and Planned Parenthood, which it claims are “beneficiaries of the Depo-Provera policy/profit system.”

Black Box Warning

In 2004, the Food and Drug Administration attached a “Black Box warning,” its highest-level caution about possible adverse effects, to Depo-Provera. The FDA mandates that patients be counseled by a health professional before they receive the drug and informed of its risk of significant and irreversible bone loss.

Other documented side effects include stroke, blood clots in lungs, limbs and eyes, loss of fertility or delayed fertility after stopping the drug, ectopic pregnancy and weight gain. The FDA also advises that the drug should not be used longer than two years.

Subsequent research by Renee Heffron, funded in part by the Bill & Melinda Gates Foundation and the National Institutes for Health, published in The Lancet last year, found that injectable hormone-based contraceptives, including Depo-Provera, increase the risk of acquiring and transmitting the HIV-1 AIDS virus.

Another study, published in Cancer Research in 2012, found that Depo-Provera doubled the risk of aggressive breast cancer in women who took the drug for a year or longer.

The Rebecca Project alleges that the Gates Foundation tried to discredit research the foundation had funded itself and manipulated regulatory authorities at the World Health Organization (WHO) to circumvent the findings — and the FDA warnings — in its campaign to promote contraceptive injections abroad.

The Rebecca Project’s Fosu, whose parents are from Ghana, published another report in 2011, “The Outsourcing of Tuskegee: Non-Consensual Research in Africa,” detailing a project that injected about 9,000 impoverished women and girls with Depo-Provera in Ghana under the guise of providing “general health care,” allegedly without obtaining informed consent or telling them that they were taking part in research or informing them of the drug’s possible life-threatening side effects.

This “Navrongo Experiment” in Ghana between 1994 and 2006 was funded by USAID, Population Council, the Bill & Melinda Gates Foundation, the Rockefeller Foundation and the Andrew W. Mellon Foundation.

Steven Mosher, executive director of the Virginia-based Population Research Institute, has been working with Fosu on the issue.

“Fosu’s groundbreaking investigation of abuses in U.S.-funded population-control programs in Africa, confirms what PRI has documented over the years,” Mosher said. “Namely, that the population controllers will stop at nothing to stop African women from having children.”

Pursuing Legal Remedies

In the last two decades, Pfizer has either lost or settled a number of lawsuits over its contraceptives. The company pulled Norplant from the American market in 2002, amidst a flurry of claims. A progestin-based contraceptive developed by Population Council, Norplant is similar to Depo-Provera in chemical composition but is implanted rather than injected.

Tens of thousands of women initially sued Wyeth Pharmaceuticals (now part of Pfizer) for allegedly failing to warn them of the side effects, including irregular bleeding, headaches and depression. In October 2011, Pfizer settled on Wyeth’s behalf for approximately $30 million, on top of the $48 million already paid by Wyeth in 1999.

Despite the fact that Norplant is no longer saleable in the United States, the World Health Organization and family-planning activists, including the Gates Foundation, openly promote a modified version of the drug in the developing world. The Rebecca Project says it has been unable to find a single record of settlement to any African woman, though “they deserve the same redress and compensation as harmed American women.”

In 1996, Pfizer conducted human experiments with a new antibiotic called Trovan in Nigeria, without informing parents of the children taking the drug that they were human experimental subjects. Dozens of children died or were permanently injured by the drug, and Nigeria’s Kano state government sued for damages. In 2009, the 2nd Circuit of the U.S. Court of Appeals found in Pfizer v. Abdullahi that international law prohibiting non-consensual experimentation allows Trovan’s victims access to U.S. courts to seek damages. Pfizer subsequently settled out of court, giving the affected Nigerians $75 million and agreeing to build them a hospital — the first ever built on African soil by a pharmaceutical company for non-experimental purposes.

In June 2010, the U.S. Supreme Court rejected Pfizer’s appeal of the 2009 appellate-court decision, which leaves U.S. courts open to foreign-experimentation litigants under some circumstances. According to Rebecca Project’s Fosu, that means “there is an explosive class-action suit coming.”

“We are going to sue in the U.S. on behalf of American women and [women] in different countries,” said Fosu. “We are going to sue the distributors of this implant and the intermediaries, including USAID and the Gates Foundation, who deliberately misinform and conceal harm from women. We are going to stop Depo-Provera.”

Florida attorney Willie Gary’s office confirmed to the Register that he is involved with the Rebecca Project’s planned litigation. Gary has won billions of dollars in lawsuits, including some against corporate giants like Disneyland and Anheuser-Busch. According to Gary’s office, he secured an out-of-court settlement of nearly $100 million, after suing Bill Gates and Microsoft in 2001 for racial discrimination, accusing them of having a “plantation mentality” about African-American workers.

Congressional Hearings

As well as pursuing judicial action, the Rebecca Project is seeking political action on Depo-Provera. In September, Rep. William Lacy Clay, D-Mo., held congressional hearings to discuss “Black Box Warnings to Protect Black Women,” during the Congressional Black Caucus Legislative Conference.

And Rep. Christopher Smith, R-N.J., the chairman of the House Subcommittee on Africa, Global Health, Global Human Rights and International Organizations, is scheduling additional congressional hearings to discuss Rebecca Project’s evidence.

Gregory Simpkins, staff director of the subcommittee, confirmed that Smith will be holding hearings on informed consent and distribution of medical drugs in Africa and elsewhere that will look at three drugs, including Depo-Provera, Trovan and Nevirapene, an HIV drug. Simpkins stressed that these are not Depo-Provera hearings or contraception hearings, but instead hearings into unethical medical research and drug distribution at which the evidence compiled by Kwame Fosu will be considered.

“We are taking the matter very seriously,” Simpkins said. “We have already talked to a number of witnesses.” The hearings are not expected to occur before February.

The Rebecca Project says Depo-Provera is unequivocally a racist issue, citing U.N. data that indicates the drug is hardly ever used by white or affluent women in America or Europe.

“There’s nothing new about this family-planning campaign for profit,” Fosu told the Register. “It’s no longer colonialism. It’s no longer slavery. But it’s the age-old cost-benefit analysis and population-control ideology. They have devalued and dehumanized black and poor people.”

Fosu said front-line aid workers are dismayed by the exploitation of poor people by population-control programs. “People are tired of this,” he said. “They’ve leaked stuff to me.”

Pro-Contraception Groups Respond

The Gates Foundation’s Katie Harris replied initially to the Register’s enquiries about the Rebecca Project’s claims by stating that the “organization and author have been discredited” and attaching a Nov. 21 letter, signed by the Rebecca Project’s executive director, Imani Walker, stating that “Mr. Kwame Fosu is no longer a member of our staff and does not represent the Rebecca Project in any capacity.”

However, Fosu was reached by the Register Dec. 12 at the Rebecca Project’s office, and a post on the organization’s website states that, on Dec. 6, the group’s ethics board had in fact terminated Walker’s position and ordered her to stop “defaming” Fosu.

Informed by the Register about Walker’s dismissal, Harris subsequently replied, “The Gates Foundation collaborates with partners and governments to give women and couples access to a broad range of voluntary family-planning services and information. The foundation doesn’t procure Depo-Provera. Our investments are to in-country service organizations that provide family-planning services according to national guidelines, as well as WHO guidelines. These guidelines take into account the manufacturer’s safety labeling and other clinical recommendations.”

The International Planned Parenthood Federation declined to address the Rebecca Project’s allegations directly.

“IPPF believes that all people should have access to the information and services they need,” IPPF spokeswoman Tia Jeewa told the Register via email. “We focus our attention on those who have unequal access to a full range of life-saving contraceptive and other sexual and reproductive health services. Those people are often poor and or vulnerable women in our societies. Through our work, we bring equity in health and rights to our clients. More than four out of five of our clients may otherwise have been denied such lifesaving benefits.”

Pfizer representative Steve Danehy issued the company’s official response to the Register’s questions about the Rebecca Project report’s allegations.

“Patient health and safety is our top priority at Pfizer,” Danehy said. “The safety and efficacy of Depo-Provera, a long-acting reversible contraception (LARC), have been well-established through numerous clinical studies around the world. Depo-Provera has provided an important contraception option to women for decades.”

USAID declined to comment to the Register about the issue.

‘They Deserve Justice’

PRI’s Mosher says the logistics of a class-action suit on the scale Fosu is talking about “would be formidable, but should be done.”

“Far too many have been harmed by the indiscriminate provision of dangerous drugs and devices, and some have even died,” Mosher said. “They and their families deserve justice.”